Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386633
Status:
COMPLETED
Last Update Posted:
2015-01-27
First Post:
2006-10-09
Brief Title:
Safety and Immunogenicity Study of Recombinant Modified Vaccinia Virus Ankara MVA Virus to Treat HIV Infection
Sponsor:
Bavarian Nordic
Organization:
Bavarian Nordic
Study Overview
Official Title:
Phase I Open Sequential Vaccination Study on Safety and Tolerability of Two Different Doses of a Recombinant MVA HIV Polytope Vaccine MVA-mBN32 in HIV-negative 18-50 Year Old Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
At the end of 2004 there were more than 40 million people infected worldwide with HIV with an estimated 16000 new infections every day Joint United Nations Programme on HIVAIDS UNAIDS 2004 The HIV epidemic threatens whole societies particularly in Africa and Asia and rates of infections in the Western countries have also increased over the last few years However despite more than 15 years of research an effective vaccine against HIV and acquired immunodeficiency syndrome AIDS has still not been developed
There is considerable evidence that cellular immune responses can effectively control HIV-1 replication during acute and chronic infections thereby possibly protecting individuals from infection and preventing the spread of HIV To be truly effective in the general population a vaccine must induce responses specific to immunologically conserved regions The epitope-based vaccine MVA-mBN32 represents a very logical approach to this problem because of its potential to elicit a polyfunctional immune response and to focus these responses to conserved epitopes
In this study the safety tolerability and immunogenicity of a recombinant MVA-BN vaccine expressing cytotoxic T lymphocyte CTL and helper T lymphocyte HTL epitopes of HIV-1 MVA-mBN32 in 36 healthy volunteers will be examined This will include a full analysis of CD4 T helper cells and CD8 CTL responses to these epitopes to establish the potential of such a homologous prime-boost vaccine approach to induce a broad cell-mediated response to different HIV antigens
There is considerable evidence that cellular immune responses can effectively control HIV-1 replication during acute and chronic infections thereby possibly protecting individuals from infection and preventing the spread of HIV To be truly effective in the general population a vaccine must induce responses specific to immunologically conserved regions The epitope-based vaccine MVA-mBN32 represents a very logical approach to this problem because of its potential to elicit a polyfunctional immune response and to focus these responses to conserved epitopes
In this study the safety tolerability and immunogenicity of a recombinant MVA-BN vaccine expressing cytotoxic T lymphocyte CTL and helper T lymphocyte HTL epitopes of HIV-1 MVA-mBN32 in 36 healthy volunteers will be examined This will include a full analysis of CD4 T helper cells and CD8 CTL responses to these epitopes to establish the potential of such a homologous prime-boost vaccine approach to induce a broad cell-mediated response to different HIV antigens
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None